Triggered sacral neuromodulation to treat neurogenic detrusor overactivity based on algorithmic classification of bladder filling status from wireless pressure data.

根据无线压力数据对膀胱充盈状态的算法分类，触发骶神经调节来治疗神经源性逼尿肌过度活动。

• 批准号: 10317462
• 负责人: Steve Majerus
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10317462
• 关键词: Activities of Daily Living; Affect; Algorithms; Autonomic Dysreflexia; Awareness; Behavior; Bladder; Botox; Catheters; Clinical; Computer software; Custom; Data; Detection; Diabetic Neuropathies; Disadvantaged; Disease; Effectiveness; Elderly; Evaluation; Event; Extravasation; Feasibility Studies; Feedback; Female; Frequencies; Future; Goals; Home; Hour; Human; Incontinence; Independent Living; Individual; Injections; Intestines; Kidney Failure; Label; Lead; Major Depressive Disorder; Measures; Meta-Analysis; Methods; Modeling; Multiple Sclerosis; Nerve; Nerve Degeneration; Outcome Measure; Parkinson Disease; Peripheral; Phase; Post-Traumatic Stress Disorders; Questionnaires; Radio; Rattus; Readiness; Reflux; Refractory; Reporting; Research; Research Project Grants; Risk; Sepsis; Sexual Dysfunction; Sheep; Signal Transduction; Social isolation; Spinal cord injury; Stroke; Symptoms; System; Technology; Testing; Time; Translational Research; Translations; Treatment Effectiveness; Urinary Incontinence; Urinary Retention; Urinary tract infection; Urine; Urodynamics; Veterans; Woman; Work; base; classification algorithm; comorbidity; decubitus ulcer; diaries; experience; fall risk; first-in-human; functional decline; implantation; improved; improved outcome; male; men; military service; neuroregulation; pressure; response; sensor; tool; translational goal; transmission process; treatment response; urinary; wireless; wireless communication; wireless sensor

Neurogenic detrusor overactivity (NDO) resulting from spinal cord injury or disorder (SCI/D) affects 80% of individuals with SCI/D. It is also associated with peripheral neurodegenerative conditions such as Parkinson’s disease, multiple sclerosis, diabetic neuropathy, or stroke. NDO causes urinary incontinence that profoundly impacts dignified, independent living, associates with numerous comorbidities and fall risk, and is a leading factor in functional decline among the elderly. Urinary incontinence contributes to social isolation and clinical depression and associates with military service and post-traumatic stress disorder in Veterans. Restoring urine storage is consistently cited as a high priority by individuals with NDO. Continuous SNM is an off-label treatment, which is effective for some individuals with NDO. Triggered sacral neuromodulation—in which SNM is applied only during the portion of the bladder fill cycle where NDO occurs—could show unique benefit in treatment in some individuals. While triggered SNM increased bladder capacity in sheep and rats, feasibility has not yet been demonstrated in humans with NDO. The primary goal of this research is to demonstrate the feasibility of increasing bladder capacity and reducing bladder filling pressures using triggered SNM in Veterans with NDO. This will expand on unique technologies developed by our team: the UroMonitor, the Context-Aware Threshold (CAT) algorithm, and the Application Specific Control Unit (ASCU). The UroMonitor is a small, transurethrally-inserted sensor that wirelessly transmits bladder pressure data. CAT is a wavelet-based algorithm that detects detrusor contractions from pressure data in real time. The ASCU is a modular neurostimulation platform supporting wireless communication and custom control software. We will modify and integrate these technologies to demonstrate the feasibility of automatically triggering SNM in Veterans. A secondary goal is to use the UroMonitor to determine bladder capacity, detrusor contraction rate, and filling pressures during a percutaneous SNM evaluation to identify individuals who respond to SNM therapy before a permanent implantation. Both translational goals will be accomplished through two Specific Aims (SA): SA1 will determine the change in bladder response to conditionally-triggered SNM during natural filling cycles after a two-week sacral neuromodulation evaluation phase in Veterans with NDO. In SA1a we will integrate a short-range radio and low-power algorithm processor into the ASCU to trigger percutaneous SNM under algorithm control. In SA1b we will develop and bench-validate a classification algorithm capable of triggering SNM based on adaptive detection of detrusor contractions. In SA1c we will apply triggered SNM using data transmitted from the UroMonitor to the ASCU. Triggered SNM will be applied for eight hours at three timepoints in the two-week percutaneous evaluation phase in eight Veterans. Voided urine volume, time between voids, and detrusor contraction frequency will be compared to determine change in conditional SNM response at the two timepoints and compared to baseline. Outcome measures will be measured from validated questionnaires, catheter-referenced bladder pressures, and collected voided urine. SA2 will determine change in bladder capacity, filling pressure, and detrusor contraction frequency during natural filling cycles throughout a two-week continuous sacral neuromodulation evaluation. In SA2a we will integrate adaptive antennas into the UroMonitor and develop an insertion tool for men and women. SA2b will demonstrate the feasibility of using the UroMonitor to characterize NDO symptoms (bladder capacity, filling pressure, and detrusor contraction rate) over several bladder filling/emptying cycles. Eight Veterans will receive standard, continuous percutaneous SNM for two weeks. NDO symptoms will be measured using the UroMonitor before SNM and after one and two weeks of continuous SNM. Accuracy of symptom quantification will be compared to standard catheter-based testing and validated urinary behavior questionnaires.

由脊髓损伤或障碍（SCI/D）引起的神经源性逼尿肌过度活动（NDO）影响80%的 SCI/D患者。它也与周围神经退行性疾病有关，如帕金森氏症 疾病、多发性硬化、糖尿病性神经病变或中风。NDO会导致尿失禁， 影响有尊严的独立生活，与许多合并症和跌倒风险相关，是一种主要的 老年人功能衰退的因素。尿失禁导致社会隔离和临床 抑郁症和退伍军人的兵役和创伤后应激障碍。 恢复尿液储存一直被NDO患者列为高度优先事项。连续SNM是 一种标签外治疗，对某些NDO患者有效。触发骶神经调节 其中SNM仅在发生NDO的囊袋填充周期的部分期间应用， 对某些人的治疗有好处。虽然触发SNM增加了绵羊和大鼠的膀胱容量， 在NDO患者中的可行性尚未得到证实。 本研究的主要目的是证明增加膀胱容量的可行性， 使用触发SNM降低NDO退伍军人的膀胱充盈压力。这将扩展到独特的 我们的团队开发的技术：UroMonitor，上下文感知阈值（CAT）算法和 专用控制单元（ASCU）。UroMonitor是一种经尿道插入的小型传感器， 无线传输膀胱压力数据。CAT是一种基于小波的逼尿肌检测算法 从真实的时间压力数据收缩。ASCU是一个模块化神经刺激平台，支持 无线通信和定制控制软件。我们将修改和整合这些技术， 证明了自动触发退伍军人SNM的可行性。第二个目标是使用 UroMonitor用于确定膀胱容量、逼尿肌收缩率和充盈压力， 经皮SNM评估，以确定在永久性治疗前对SNM治疗有反应的个体。 置入这两个转化目标将通过两个具体目标（SA）来实现： SA 1将确定在自然充盈期间膀胱对条件性触发SNM的响应的变化 两周骶神经调节评价阶段后，对NDO退伍军人进行了两个周期的治疗。在SA 1a中，我们将 将短程无线电和低功耗算法处理器集成到ASCU中，以触发经皮SNM 在算法控制下。在SA 1b中，我们将开发并对分类算法进行基准验证， 基于逼尿肌收缩的自适应检测触发SNM。在SA 1c中，我们将应用触发SNM 使用从UroMonitor传输到ASCU的数据。触发的SNM将在三点应用八小时 在8名退伍军人的两周经皮评价阶段的时间点。排尿量、时间 将比较排尿和逼尿肌收缩频率，以确定条件SNM的变化 两个时间点的反应并与基线进行比较。结果指标将根据经验证的 问卷调查、导管参考膀胱压力和收集的排尿。 SA 2将确定膀胱容量、充盈压和逼尿肌收缩频率的变化， 在为期两周的连续骶神经调节评价中的自然充盈周期。在SA 2a中，我们将 将自适应天线集成到UroMonitor中，并为男性和女性开发插入工具。SA 2B将 证明使用UroMonitor表征NDO症状（膀胱容量、充盈）的可行性 压力和逼尿肌收缩速率）。八名退伍军人将 接受标准的连续经皮SNM两周。NDO症状将使用 SNM前和连续SNM一周和两周后的UroMonitor。症状量化的准确性 将与标准的基于导管的测试和经验证的排尿行为问卷进行比较。